510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K895406 | Osbon Personal Lubricant | Osbon Medical Systems, Ltd. | KMJ | Class I | |
| K895362 | Bactec Pyrazinamide Susceptibility Test | BD Becton Dickinson Vacutainer Systems Preanalytic | JTT | Class II | |
| K895157 | S.a.f. Acetabular Cup | Synergy Orthopaedics Intl., Inc. | KWA | Class III | |
| K894986 | 3-Ring Handle, Grasp Forceps, Loop Retrie., Basket | North American Sterilization & Packaging Co. | OCZ | Class II | |
| K892890 | Steth-Shield(tm) | North East Technology | DQD | Class II | |
| K892279 | Patient Examination Gloves | Aek Rubber Product Sdn. Bhd. | LYY | Class I | |
| K891493 | Patient Examination Gloves (Latex) | Cinderella Ent. Co., Ltd. | LYY | Class I | |
| K883400 | Optum(tm) Automated Patient Assist Device | Abbott Medical | KPE | Class II | |
| K896537 | Porges Hot Biopsy Forceps | Porges Corp. | KGE | Class II | |
| K896117 | Modified Model 535(Tm) Luminometer | Los Alamos Diagnostics | JJQ | Class I | |
| K896090 | Devilbiss Model 6300D | Devilbiss Health Care, Inc. | EPN | Class I | |
| K895966 | Magnetom M, H, 42, 63, 42 Sp and 63 Sp | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K895518 | Coherent Holmium:yag Surgical Laser | Lumenis Ltd | GEX | Class II | |
| K895278 | Scd Knee Immobilizer | Kendall Healthcare Products Co. Div.Of Tyco Health | JOW | Class II | |
| K894882 | Infiltration Pump Syringe | R. J. Doyle, Inc. | BSP | Class II | |
| K894881 | 20Ga X 7-1/2 Threading Bullet Point Needle | R. J. Doyle, Inc. | BSP | Class II | |
| K894880 | 16Ga X 14 Fourteen Long Long Bullet Point Needl | R. J. Doyle, Inc. | BSP | Class II | |
| K894879 | 16Ga X 10 Middle Size Bullet Point Needle | R. J. Doyle, Inc. | BSP | Class II | |
| K894878 | 16Ga X 6 Bullet Point Needle, Flex Stainless Stee | R. J. Doyle, Inc. | BSP | Class II | |
| K894541 | Carrington Dermal Wound Gel | Carrington Laboratories, Inc. | FRO | Unclassified | |
| K894446 | Angeion Hemostasis Valve Introducer | Angeion Corp. | DYB | Class II | |
| K894093 | Spacelabs Model 90900 | Spacelabs, Inc. | LOS | ||
| K892721 | Ifa Sensibac Cefaclor | Investigacion Farmaceutica S.A. de C.V. | JTN | Class II | |
| K892584 | Ton-Su's Vinyl Exam Gloves | Ton SU Co., Ltd. | LYZ | Class I | |
| K890310 | Sterile Foley Catheter | Kosan Far East Ent., Ltd. | EYC | Class II | |
| K896433 | Modified Rubagen | Biokit USA, Inc. | LQN | Class II | |
| K896109 | Immunocard Strep a Test | Disease Detection International, Inc. | GTZ | Class I | |
| K895959 | Brevet Floss Pick (Cold Sterilization Fluids) | Brevet Inc. | EKJ | Class I | |
| K895851 | Synchron Cx(r) Systems Hdl Cholesterol Reagent | Beckman Instruments, Inc. | LBS | Class I | |
| K895780 | Oscaroxy(tm) Gas Monitor and Pulse Oximeter | Datex Division Instrumentarium Corp. | CCK | Class II | |
| K895745 | Sickle Cell Solubility Test Kit | Simmler Inc | JBB | Class II | |
| K895519 | Sure & Natural(tm) Unscented Menstrual Pad | Personal Products Co. | HHD | Class I | |
| K895440 | Quinton Mahurkar Catheters W/vitacuff | Quinton, Inc. | DQY | Class II | |
| K895422 | Tower Self Seal Sterilization Pouch | Baxter Healthcare Corporation | JOJ | Class II | |
| K895403 | Aspirette Endocervical Aspirator | Unimar, Inc. | HFC | Class II | |
| K895352 | Kendall Infant Ecmo Venovenous Catheter-Dual Lumen | Kendall Healthcare Products Co. Div.Of Tyco Health | DWF | Class II | |
| K895333 | Osseodent Prosthetic Kit | Celtrix Laboratories | DZE | Class II | |
| K895103 | Accuprobe Enterococcus Culture Confirmation | Hologic, Inc. | GTZ | Class I | |
| K893903 | Kronamax Kube | Physicians Digital Co. | KQX | Class I | |
| K893794 | Apexit Root Canal Sealer | Williams Dental Co., Inc. | KIF | Class II | |
| K896392 | Medtronic Epidural Catheter Kit Model 8717 | Medtronic, Inc. | CAZ | Class II | |
| K896110 | Biobrane(r) II | Sterling Drug, Inc. | KGN | Unclassified | |
| K896051 | Lone Star Trading Surgical Glove | Lone Star Trading Pte., Ltd. | KGO | Class I | |
| K895530 | Standard Condom | Mayer Laboratories | HIS | Class II | |
| K895430 | Heraeus Lasersonics Nd:yag Laser, Model Luxus 100 | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K895429 | A&d Automatic Digital Blood Pressure Meter 2650 | A and D Engineering, Inc. | DXN | Class II | |
| K895428 | A&d Automatic Digital Blood Pressure Meter 2510/20 | A and D Engineering, Inc. | DXN | Class II | |
| K895336 | Abbott Inpersol Cycler 1000 | Abbott Medical | FKX | Class II | |
| K895150 | Continucath 1000 Intravascular Oxygen Monitoring | Shiley, Inc. | CCE | Class II | |
| K895149 | Neocath 1000 Umbilical Artery Oxygen Monitoring Sy | Shiley, Inc. | CCE | Class II |